NANOTITE™ CERTAIN® NIOSS413Recalls & reported problems
ZimVie US Corp LLC · NANOTITE TM CERTAIN® IMPLANT 4 X 13MM · Class 2 · Implant
All models of NANOTITE CERTAIN (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868011354), received between Mar 11, 2020 and Oct 8, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Mechanical Problem1
Patient problems
- Inflammation1
- No Code Available1
- No Information1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; No Code Available; Pain; Unspecified Infection
MAUDE report 10647502 ↗InjuryMar 11, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT CAME TO MEDICAL CENTER DUE TO CROWN LOOSENING AND MOBILITY OF IMPLANT. WHEN CHECKING THE IMPLANT, DOCTOR NOTICED THAT THE INTERNAL IMPLANT HEX WAS DAMAGED AND THE SCREW WAS LOOSE. THE IMPLANT IN DENTAL SITE 4 WAS REMOVED.
Patient problems: No Information
MAUDE report 9816959 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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